Production Pharmacist

Cilo Cybin; Centurion; On-site; ZAR 600,000 - 900,000; Full time

Job summary

A pharmaceutical manufacturing company in Centurion seeks a qualified pharmacist to oversee strict compliance with manufacturing regulations and ensure quality management. This role involves supervising production, preparing SOPs, maintaining documentation, and addressing customer complaints. Applicants should have a Bachelor of Pharmacy degree, be registered with the South African Pharmacy Council, and possess a minimum of 2 years of experience in a GMP environment. Safety and compliance are top priorities in this position.

Qualifications

• Bachelor of Pharmacy (B.Pharm) Degree.
• Registered as a practicing pharmacist with the South African Pharmacy Council (SAPC).
• Minimum of 2 years of experience in a pharmaceutical GMP manufacturing/production facility.

Responsibilities

• Ensure compliance with current Good Manufacturing Practices (cGMP) and other regulations.
• Prepare, update, and approve Standard Operating Procedures (SOPs).
• Create and manage production plans to meet delivery timelines.
• Conduct internal audits and address audit findings.
• Maintain accurate documentation and record keeping.
• Ensure products are produced, packed, stored per SOPs and documentation.
• Verify dispensing of raw materials with mass/volume accuracy.
• Oversee addition of raw materials into product mixes and correct handling of materials.
• Maintain good housekeeping and monitor environmental conditions.
• Participate in internal inspections and address audit findings.

Skills

GMP compliance

GDP

Leadership

Quality control

Education

Bachelor of Pharmacy (B.Pharm) Degree

Job description

• Ensure strict compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practice (GDP), hygiene, and good housekeeping.
• Ensure activities are executed in accordance with the SA Pharmacy Act 53 of 1974 and its amendments, as well as the Medicines and Related Substances Control Act No. 101 of 1965 and its amendments.

Standard Operating Procedures (SOPs) Management

• Prepare, update, review, and approve Standard Operating Procedures (SOPs).
• Ensure SOP training is conducted in line with the training plan.
• Oversee induction training for new production personnel.

Manufacturing & Production Oversight

• Create and manage production plan to ensure product is delivered as per required timelines.
• Supervise line opening/clearance, in-process checks (IPC), and line closing as per SOPs.
• Monitor critical process parameters at various manufacturing stages to ensure compliance.
• Ensure that products are produced, packed, and stored according to required SOPs and documentation.
• Verify the dispensing of raw materials, including mass and volume accuracy.
• Oversee and sign off on the addition of raw materials into product mixes.
• Ensure correct handling, storage, and recording of materials and products.
• Verify the identity of bulk products and printed packaging materials before use.

Housekeeping & Environmental Monitoring

• Maintain and enforce good housekeeping practices.
• Monitor and ensure that environmental parameters (pressure, temperature, humidity) remain within specifications.
• Ensure equipment is properly cleaned and calibrated.
• Oversee the adequacy and maintenance of the GMP area, ensuring space, cleanliness, and physical integrity (no leaks, cracks, etc.).

Internal Audits & Inspections

• Participate in and conduct internal inspections as scheduled.
• Ensure audit findings are addressed and closed on time as per the corrective action plan.

Documentation & Record Keeping

• Ensure batch manufacturing/packing records are complete before submission to QA.
• Maintain accurate and up-to-date registers for scheduled substances (narcotics).
• Ensure adherence to and timely completion of all required records, reports, and documentation as per relevant SOPs and protocols.

Quality Management System (QMS) Compliance

• Initiate, investigate, and close deviations to prevent recurrence.
• Raise Corrective and Preventive Actions (CAPAs) and Change Controls, ensuring timely closure and effective implementation.
• Report non-conformities related to both the product and environmental conditions.
• Conduct root cause investigations and implement corrective actions promptly.
• Perform risk assessments to mitigate potential production issues.

Customer Complaints Management

• Conduct thorough investigations into all customer complaints.
• Compile and submit detailed reports promptly.
• Ensure CAPAs are implemented effectively to prevent recurrence.

Validation, Qualification & Calibration

• Facilitate and participate in qualification and validation studies.
• Ensure proper calibration of equipment to maintain accuracy and compliance.

Staff Management

• Provide direct leadership and supervision to the manufacturing team.
• Manage production personnel through planning daily activities and ensuring delivery to production schedule.
• Manage production staff to ensure production personnel strictly adhere to cGMP practices.
• Monitor and enforce the correct use of Personal Protective Equipment (PPE) during manufacturing.
• Report and address any unsafe practices or behaviors.

Qualifications & Experience

• Bachelor of Pharmacy (B.Pharm) Degree.
• Registered as a practicing pharmacist with the South African Pharmacy Council (SAPC).
• Minimum of 2 year of experience in a pharmaceutical GMP manufacturing/production facility.